Proponents of new technology see it as cool, new and needing special treatment – but the FDA has seen it all before…
Archives for September 2013
FDA has issued the keenly awaited final guidance on Mobile Medical Apps. There are no surprises – and the Agency intends a light touch approach to most Apps.
The Taiwan FDA continues to fine tune its regulation of online sales of devices, this time issuing a proposal to relax a current ban on online sales of a range of Class II devices.
UDI gives us a standard identifier for postmarket regulation and provides an early win for IMDRF. Here’s an overview and a downloadable quick guide to UDI.
New guidance published by TGA clarifies that apps are treated the same way as other software devices.